Phase 3
Completed N=423
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
Type 2 Diabetes Mellitus · Renal Insufficiency, Chronic
Source: ClinicalTrials.gov NCT00509262 ↗
Enrolled (actual)
423
Serious AEs
17.5%
Results posted
Mar 2012
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 — 7.76; 7.79; -0.70; -0.62 Percent of glycosylated hemoglobin
Summary
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 |
7.76; 7.79; -0.70; -0.62 | — |
| PRIMARY Percentage of Participants With Hypoglycemic Events |
6.2; 17.0 | 0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 |
148.6; 143.9; -16.7; -20.2 | — |
| SECONDARY Change From Baseline in Body Weight at Week 54 |
-0.6; 1.2 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Has type 2 diabetes mellitus
- Has moderate or severe renal insufficiency
Exclusion Criteria
- Has type 1 diabetes mellitus or a history of ketoacidosis
- Is on a new weight loss program
- Has active liver disease
- Is on dialysis or is likely to need dialysis during the study
Data sourced from ClinicalTrials.gov (NCT00509262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.